Brain scans aim to unlock Parkinson's secrets
NCT ID NCT05516732
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study uses advanced brain scans (PET and MRI) to examine serotonin activity in people with Parkinson's disease. Researchers will compare brain images from 42 participants at different stages of the disease. The goal is to find biological markers that could lead to new treatments to slow the condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could help identify brain changes that lead to new medications to slow Parkinson's progression.
- What could go wrong
- This is an early observational study with only 42 participants, so findings may not apply to everyone. It does not test a treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2022
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
A cohort of carriers of genetic mutations for familial forms of Parkinson's Disease, Idiopathic Parkinson's Disease patients, and previously collected data from healthy controls
- Ages
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25 to 85 years
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria- * Subjects must understand the nature of the study and must provide signed and dated written HRA-approved informed consent in accordance with local regulations before any protocol-specific screening procedures are performed; * Males and females, age 25-85 years, inclusive; * Women of child-bearing potential must use protocol-defined contraceptive measures and must have a negative β-hCG test at screening. For sexually active subjects (except females of non-childbearing potential-e.g., at least 2 years postmenopausal or surgically sterile), condoms should be used in addition to other birth control methods for the duration of the study and for 3 months after the last administration of PET or SPECT ligands. These patients must be willing to remain on their current form of contraception for the duration of the study. All male subjects must agree to refrain from donating sperm for the duration of the study and for 3 months after the last administration of PET or SPECT ligands. Sexually active male subjects must agree to use condoms to protect their partners from becoming pregnant for the duration of the study and for 3 months after the last administration of PET or SPECT ligands (i.e. for 15 consecutive months following baseline PET and SPECT scans); agree to ensure that they and their partners are routinely using a medically approved contraceptive method. It is important that male subjects not impregnate others for the duration of the study and for 3 months after the last administration of PET or SPECT ligands; * Able and willing to participate in all scheduled evaluations, abide by all study restrictions, and complete all required tests and procedures; * Adequate visual and auditory acuity to complete the psychological testing; * In the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study. Exclusion criteria - * Subjects lacking capacity according to investigator judgement; * Subjects taking serotonin acting drugs such as antidepressants (i.e. tricyclic or selective serotonin reuptake inhibitors etc.); * Pregnancy or breastfeeding or intent to become pregnant in the next 18 months; * Subjects with current or a recent history of drug or alcohol abuse/dependence; * Subjects who have other neurological disorders and known intracranial co-morbidities such as stroke, hemorrhage, space-occupying lesions; * Presence of any clinically significant medical condition (including cardiovascular, respiratory, cerebrovascular, hematological, hepatic, renal, gastrointestinal, or other disease) that, based on the judgment of the investigator, is clinically unstable, is likely to deteriorate during the course of the study, could put the patient at risk because of participation in the study, could affect the subject's ability to complete the study, or could influence the study results; * History of suicidal behaviour or active suicidal ideation; * Within 1 year prior to screen or between screen and baseline (Day -1), any of the following: myocardial infarction; hospitalization for congestive heart failure; hospitalization for, or symptoms of, unstable angina; or syncope not related to PD; * History or presence of renal disease or impaired renal function; * Clinically important infection (e.g., chronic, persistent, or acute infection) within 30 days prior to screen or between screen and baseline (Day -1); * History of cancer within the last 5 years, with the exception of nonmetastatic basal cell carcinoma of the skin; * Clinically significant blood clotting or bleeding disorder, including clinically significant abnormal findings in laboratory assessments of coagulation or hematology; * Use of antipsychotic medication within 3 months prior to screen or between screen and baseline (Day -1); * Use of any anticoagulant within 30 days prior to baseline and follow-up PET scans; * Use of any oral corticosteroid within 30 days prior to baseline and follow-up PET scans; * Use of metoclopramide within 30 days prior to baseline and follow-up (Day -1); * Use of any thyroid medication within 30 days prior to baseline and follow-up (Day -1); * Regular use (e.g., taken \> 3 days/week) of narcotic pain medications within 30 days prior to baseline and follow-up (Day -1); * Presence of any of the following MRI contraindications: pacemaker; cardiac defibrillator; spinal cord or vagus nerve stimulator; aneurysm clip; artificial heart valve; recent coronary or carotid stent; ear implant; CSF shunt; other implanted medical device (e.g., Swan-Ganz catheter, insulin pump); or metal fragments or foreign objects in the eyes, skin, or body; * Negative modified Allen test in both hands, unless the brachial artery is used for arterial cannulation; * Claustrophobia or history of back pain that makes prolonged laying on the PET or MRI scanner intolerable; * History of severe skin allergy; * Patients who had previous surgery for PD (including but not limited to deep brain stimulation \[DBS\] or cell transplantation); * Patients who are treated with duodopa or apomorphine; * Initiation or change in pharmacologic therapy for symptoms of PD within 30 days prior to screen or between screen and baseline and follow-up (Day -1). * GDS score greater than or equal to 10 (GDS score of 5 - 9 requires Investigator discretion to enter study). * STAI Form Y-1 greater than or equal to 54 requires Investigator discretion to enter study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Of Exeter
RECRUITINGExeter, Devon, EX1 2LU, United Kingdom
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